Attend this webinar to understand the new requirements of the medical devices regulation EU IVDR 2017/746 in the European Union and get ready to receive the new certificates until May 2022.
Why Should You Attend:
The new in vitro diagnostic medical devices regulation EU IVDR 2017/746 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of these changes and how to implement changes until May 2022 is essential to receive the new certificates until May 2022. The first key for the understanding and the implementation of the changes is the knowledge about the new requirements for the IVD-products. The second key is to understand, which changes need the quality management system according the ISO 13485:2016, which need more processes under the new IVDR as outlined in the ISO 13485:2016. These not covered paragraphs and requirements must be additional implemented into the quality management system until May 2022. The time is short and immediately action is required. Without the new certificates your sales activities in Europe are interrupted.Learning Objectives:
Introduction, who must apply the new EU MDR 2017/746 requirements?- Overview about the changes of the EU MDR 2017/746 regarding quality management
- What are the interfaces between the EN ISO 13485:2016 and the EU IVDR 2017/746
- Which new requirements of the EU IVDR 2017/746 are not covered by the EN ISO 13485:2016?
- Smart and fast ways to implement the changes in your quality management system
- Fast track internal audit to approve the changes
Areas Covered in the Webinar:
- The new scope of the EU IVDR 2017/746
- The obligations and roles of the EU IVDR 2017/746
- How work the regulation and the EN ISO 13485:2016 together?
- New and updated processes required by the EU IVDR 2017/746
- How to implement the required changes until May 2022?
Who Will Benefit:
- CEO’s, product manager, quality/regulatory/medical affairs manager, quality representatives of
- IVD manufacturers
- IVD importers
- IVD distributors and
- IVD dealers
- who work with European Union
Speaker
Frank SteinCourse Provider
Frank Stein,
